different doses of tyrosine adsorbed grass pollen allergoid with monophosphoryl lipid a (mpl) in patients sensitized to grass pollen

Conditions: Type I Hypersensitivity

Summary: allergen-specific immunotherapy (sit), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. grassmatampl has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass pollen (hay fever). the purpose of this double-blind phase iib study is to assess the tolerability and immunogenicity of different doses of grassmatampl in volunteers allergic to grasses and rye pollen.


Eligibility criteria:
inclusion criteria: * positive skin prick test for grass and rye allergen * specific ige for grass and rye as documented by radioallergosorbent or equivalent test with class \>= 2 * history of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an ige - mediated allergy to pollen from grass and rye * males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method. * spirometry at screening demonstrates fev1 \>= 80% predicted and fev1/fvc \>= 70% exclusion criteria: * acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis * patient has moderate to severe asthma * visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing * history or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders * recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders * any clinically significant (as determined by the investigator) abnormal laboratory value * perennial allergens: clinically relevant sensitivity against house dust mites, molds, and epithelia * patient has clinically relevant sensitivity against the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, bermuda grass, or ragweed. * secondary alteration at the affected organ * history of autoimmune diseases and/or rheumatoid diseases * patient is taking b-blockers * patient who is not allowed to receive adrenalin * patients in whom tyrosine metabolism is disturbed * presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study * documented evidence of acute or significant chronic infection * history of anaphylaxis * documented history of angioedema * hypersensitivity to excipients in the study medications * previous or current immunotherapy with comparable grass/rye allergen extracts * currently using anti-allergy medication and other drugs with antihistaminic activity * patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days * patient is pregnant or planning pregnancy and/or lactating * patient has received treatment with preparation containing mpl® during the past 12 months * any systemic disorder that could interfere with the evaluation of the study medication(s) * clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study

Keywords: allergy specific immunotherapy